Ex Parte Prater et al

Patent Trial and Appeal Board

Aug 2, 2018

11603766 (P.T.A.B. Aug. 2, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
11/603,766 11/22/2006 Derek Allan Prater
26111 7590 08/06/2018
STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
1100 NEW YORK A VENUE, N.W.
WASHINGTON, DC 20005
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
1861.3300002/JMC 3704
EXAMINER
VU, JAKE MINH
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
08/06/2018 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
e-office@stemekessler.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DEREK ALLAN PRATER, MOHAMMED HASSAN,
CHRISTOPHER ROBERT BLAND 1
Appeal2017-008320
Application 11/603,7662
Technology Center 1600
Before TONI R. SCHEINER, RICHARD M. LEBOVITZ, and, TIMOTHY
G. MAJORS, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a delayed release
pharmaceutical composition that provides a lag in the delivery of a drug
following administration. The Examiner finally rejected the claims as
obvious under 35 U.S.C. § 103(a). Appellants appeal the rejections pursuant
to 35 U.S.C. § 134. We have jurisdiction for the appeal under 35 U.S.C.
§ 6(b ). The rejections are reversed.
1 The Appeal Brief ("Appeal Br.") at page 3 lists Euro-Celtique S.A. as the
real-party-in-interest.
2 The application is referenced as "the '766 Specification."
Appeal2017-008320
Application 11/603,766
STATEMENT OF THE CASE
Claims 24--33, 35, 37, 39, 42, and 45-53 stand finally rejected by the
Examiner as unpatentable. The rejections are as follows:
1. Claims 24--33, 35, 37, 39-42, and 45-51 under 35 U.S.C. § I03(a)
as obvious in view of Buxton et al. (EP O 527 638 Al, published Feb. 17,
1993) ("Buxton"), Katzhendler et al. (U.S. Pat. No. 5,980,942, issued Nov.
9, 1999) ("Katzhendler"), and Grimmett et al. (U.S. Pat. No. 6,358,528 Bl,
issued Mar. 19, 2002) ("Grimmett"). Ans. 2.
2. Claims 24--33, 35, 37, 39-42, and 45-53 under 35 U.S.C. § I03(a)
as obvious in view of Buxton, Katzhendler, Grimmett, and Curatolo et al.
(U.S. Pat. No. 6,068,859, issued May 30, 2000) ("Curatolo"). Ans. 6.
3. Claims 24--33, 35, 37, 39, 42, and 45-53 are rejected under 35
U.S.C. § I03(a) as obvious in view of Curatolo as "evidenced" by Banjanac
et al. (Pharmacol. Res., 66(4):357-62, 2012 (Abstract) ("Banjanac"). Ans.
7.
There are two independent claims on appeal, composition claim 24
and method claim 46 which comprises administering the same composition
of claim 24. Claim 24 is reproduced below:
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Application 11/603,766
24. A delayed release pharmaceutical composition which
provides a lag in delivery of a drug following administration,
the composition comprising a multi-unit dosage of
multiparticles, each unit of the composition comprising
(a) a core which includes a drug and a disruption agent
and
(b) a regulatory membrane coating on the core formed
from a mixture of a water-soluble gel-forming polymer and a
water-insoluble film-forming polymer;
wherein said water-soluble gel-forming polymer is a high
viscosity grade hydroxyalkylcellulose or methyl cellulose, said
water-insoluble film-forming polymer is an alkyl cellulose, and
wherein there is a coating weight gain of said regulatory
membrane coating of between 20% and 100%, and
wherein said composition releases less than 10% of the
drug in the lag period of up to 1 to 6 hours, and after said lag
period, releases more than 90% of the drug over a release
period of not greater than 6 hours.
CLAIMS
The claimed delayed release pharmaceutical composition recited in
claims 24 and 46 comprises: (a) a core; and (b) a regulatory membrane
coating on the core.
The regulatory membrane comprises: (1) a water soluble gel-forming
polymer which is a high viscosity grade hydroxyalkylcellulose or methyl
cellulose; and (2) a water-insoluble film-forming polymer which is an alkyl
cellulose. In claim 35, the water soluble gel-forming polymer is high
viscosity grade hydroxypropylmethylcellulose.
The composition has a functional limitation that the composition
"releases less than 10% of the drug in the lag period of up to 1 to 6 hours,
and after said lag period, releases more than 90% of the drug over a release
period of not greater than 6 hours."
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Application 11/603,766
REJECTION BASED ON BUXTON, KATZHENDLER, AND
GRIMMETT
The Examiner found that Buxton describes a controlled delivery
pharmaceutical composition with a spheroid core and controlled released
coating material, which corresponds to the claimed (a) core and (b)
regulatory membrane coating, respectively. Ans. 2-3. The Examiner also
found that Buxton describes a coating comprising the same (1) water-soluble
gel-forming and (2) water-insoluble film-forming polymers as claimed. Id.
at 3. The Examiner acknowledged that Buxton does not disclose that the (1)
water soluble gel-forming polymer is a high viscosity grade
hydroxyalkylcellulose or methyl cellulose as required by all the claims.
However, the Examiner found that Katzhendler teaches that
hydroxypropylmethylcellulose ("HPMC"), a hydroxyalkylcellulose as
claimed (see dependent claim 35), is available in "low, normal or high
viscosity grades," making it obvious to have used the high viscosity grade.
Id. The Examiner also cited Grimmett as teaching that binders such as
hydroxypropylmethylcellulose and hydroxypropylcellulose, limitations
recited in dependent claims 31 and 32, were known in the art. Id. at 4.
With respect to the recited lag period, the Examiner found, citing the
'766 Specification, that "the ratio of water insoluble to water soluble
material will depend on the release rate required and the solubility of the
material." Ans. 3. The Examiner also found that Appellants had stated in
the Appeal Brief that "the claimed result is simply a 'desired release rate
profile', wherein ... , the time of releasing a drug in a composition (release
rate profile) is clearly a result effective parameter that a person of ordinary
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skill in the art would routinely optimize by changing/increasing/decreasing
the polymers." Ans. 10. The Examiner stated that it would have been
"customary for an artisan of ordinary skill to determine the optimal amount
of each polymer to add in order to best achieve the desired results, such as
amount of drug release and the timing of the drug release." Id.
The issue in this rejection is not whether the ordinarily skilled person
could have achieved the claimed lag period and release rate by routine
optimization, but whether there would have been reason to optimize the
cited prior art to arrive at the claimed lag period and release rate.
In making an obviousness determination, "it can be important to
identify a reason that would have prompted a person of ordinary skill in the
relevant field to combine the elements in the way the claimed new invention
does." KSR Int'! Co. v. Teleflex, Inc., 550 U.S. 398,418 (2007). The reason
does not have to be explicit, and "may be found explicitly or implicitly: 1)
in the prior art references themselves; 2) in the knowledge of those of
ordinary skill in the art that certain references, or disclosures in those
references, are of special interest or importance in the field; or 3) from the
nature of the problem to be solved." Ruiz v. A.B. Chance Co., 234 F.3d 654,
665 (Fed. Cir. 2000). However, a reason must still be identified.
In this case, the Examiner did not provide a reason to have achieved
the claimed release rate and lag period. Buxton was cited for teaching a core
and regulatory membrane as claimed. Ans. 2-3. Katzhendler was cited for
teaching high viscosity grade HPMC as required by the claim. Id. at 3. The
Examiner stated that it would be obvious to use Katzhendler' s material in
Buxton "because it would allow the practitioner to adjust the drug release
rate to the desired level." Id. at 4. However, the Examiner did not provide a
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reason that would have prompted the skilled worker to adjust the release rate
such that the pharmaceutical "releases less than 10% of the drug in the lag
period of up to 1 to 6 hours, and after said lag period, releases more than
90% of the drug over a release period of not greater than 6 hours" as recited
in both independent claims. While it may be correct it is conventional to
adjust polymer types and amounts to achieve a desired release rate, the
Examiner did not point to any disclosure in the cited publications, or provide
other sufficiently persuasive reasoning, that would have guided the skilled
worker to the release profile which is claimed. The Examiner cited
disclosure in Buxton that the core of its pharmaceutical composition is
coated with a control release coating material, but did not explain how such
a coating suggested the recited lag period or inherently possessed it. Ans. 3.
The Examiner stated that "it has been held that the recitation that an
element is 'capable of performing a function is not a positive limitation, but
only requires the ability to so perform." Ans. 5. We do not agree that the
recited lag period is not a "positive" limitation of the claims. The claims
positively require that the composition have the recited release rate
"following administration." To the extent that the claimed composition must
only be "capable" of achieving the lag and release period when ingested, the
Examiner is not relieved of the burden of providing a reason to have made a
composition with such a property when administered.
The Examiner also stated:
the prior art's composition is inherently capable of a delay
period of 1 to 2 hours and release the entire content of the drug
over a period of not greater than 6 hours or a controlled release
period of over 1 to 12 hours, since the prior art's ingredient in
the composition is the same as Appellant's compositional
ingredient.
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Ans. 5.
As held in In re Swinehart, 439 F.2d 210, 212-13 (CCPA 1971)
( emphasis added):
[W]here the Patent Office has reason to believe that a
functional limitation asserted to be critical for establishing
novelty in the claimed subject matter may, in fact, be an
inherent characteristic of the prior art, it possesses the authority
to require the applicant to prove that the subject matter shown
to be in the prior art does not possess the characteristic relied
on.
Furthermore:
Where, as here, the claimed and prior art products are
identical or substantially identical, or are produced by identical
or substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed product.
See In re Ludtke, supra. Whether the rejection is based on
"inherency" under 35 U.S.C. § 102, on "prima facie
obviousness" under 35 U.S.C. § 103, jointly or alternatively,
the burden of proof is the same, and its fairness is evidenced by
the PTO's inability to manufacture products or to obtain and
compare prior art products. See In re Brown, 459 F.2d 531, 59
CCPA 1036 (1972).
In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
The Examiner did not establish that Buxton describes a composition
that would inherently possess the functional limitation of the recited lag
period. The Examiner did not identify a single example, range of values, or
ratios of the recited polymers that would meet the claimed functional
limitation to give rise to a reason to believe the composition inherently
possessed the claimed release rate. See also Appeal Br. 11-13 ( explaining
the failure of Buxton to disclose controlled release examples comprising the
recited polymers). For example, while Buxton teaches both water-soluble
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and water-insoluble polymers (Buxton 3:38--45), the Examiner did not
provide a reason for making a delayed release composition with a lag period,
rather than a composition with sustained single-release rate. The Examiner
states that the same polymers are disclosed in Buxton, but does not identify
an example in which the same polymers are combined in such a way that
they necessarily would have resulted in a composition with the claimed lag
period and release rate.
In addition, Buxton teaches that its core and coating have different
drugs and different release rates. Buxton, Abstract (57). The Examiner did
not explain why one of ordinary skill in the art would have used the same
drug in both the core and coating.
In sum, the Examiner did not provide adequate "reason to believe"
that Buxton's core and coating inherently "releases less than 10% of the
drug in the lag period of up to 1 to 6 hours, and after said lag period, releases
more than 90% of the drug over a release period of not greater than 6 hours."
With respect to Katzhendler, as discussed by the Appellants,
Katzhendler teaches the person of ordinary skill in the art that its polymers
are used in its compositions to provide a zero-order release rate.
Katzhendler, Abstract, col. 1, 11-25. "Zero order release rate" is defined in
column 3, lines 39--40, of Katzhendler as "a constant, linear, continuous
sustained and controlled release rate." See Appeal Br. 15. Thus, we agree
with Appellants that the evidence does not establish that Katzhendler would
have guided the skilled worker to a release rate with a lag period as claimed.
Id. at 16.
Grimmett is relied upon by the Examiner for teaching that binders
such as hydroxypropylmethylcellulose and hydroxypropylcellulose were
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known in the art. Ans. 4. Grimmett also describes a release retarding
coating, including release after an initial delay. Grimmett, col. 1, 11. 16-22;
Appeal Br. 16. However, the Examiner did not establish that this coating
meets or suggests the claimed regulatory coating, and Appellants provided
evidence that it does not. Appeal Br. 16-17.
Because the Examiner did not meet the burden in establishing that the
cited combination of Buxton, Katzhendler, and Grimmett suggests the
composition recited in claims 24 and 46, and dependent claims 25-33, 35,
37, 39-42, 45, and 47-51, the obviousness rejection is reversed.
REJECTION BASED ON BUXTON, KATZHENDLER, GRIMMETT,
AND CURATOLO
The Examiner relied on Buxton, Katzhendler, and Grimmett for the
same reasons as discussed above. Ans. 6. The Examiner further cited
Curatolo for teaching using high viscosity grade hydroxypropyl
methylcellulose, such as K4M. It appears that Curatolo was additionally
cited because claims 52 and 53 recite that the high viscosity grade gel
forming polymer is, inter alia, hydroxypropylmethylcellulose K4M. We
reverse the rejection of claims 24--33, 35, 37, 39-42, and 45-53, as well,
because the Examiner did not cite Curatolo for making up the deficiencies
described above for Buxton, Katzhendler, and Grimmett.
REJECTION BASED ON CURATOLO AND BANJANAC
The Examiner found that Curatolo describes a controlled delivery
pharmaceutical composition with a spheronization core and coating material,
which corresponds to the claimed (a) core and (b) regulatory membrane
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coating, respectively. Ans. 7. The Examiner also found that Buxton
describes a coating comprising the same (1) water-soluble gel-forming and
(2) water-insoluble film-forming polymers as claimed. Id.
With respect to the recited lag period, the Examiner, like in the
Buxton rejection, asserts that Curatolo "teaches all the limitations as claimed
by Appellant. Thus, adjusting the amount would have been a routine
optimization step to attain any desired release rate." Ans. 28. However, as
explained above, the issue is not whether the claimed release rates could
have been achieved by optimizing the polymer amounts used, but whether
the Examiner has provided a sufficient reason on this record for the
ordinarily skilled person to obtain the claimed release rates
To begin, we note that Curatolo describes a delayed release dosage
which, e.g., "releases not more than about 10% of its incorporated
azithromycin in the stomach, and which releases no more than an additional
10% during the first 15 minutes after the dosage form has entered the
duodenum" and the rest after moving distally through the intestine.
Curatolo, col. 2, 11. 32--44.
However, as argued by Appellants, Curatolo also describes a
sustained-released dosage formation which comprises different polymers
than the delayed-release form. Appeal Br. 22. A sustained release dosage
slowly releases drug, but does not necessarily have a delayed release with a
lag period. Curatolo, vol. 5, 11. 30--46. The Examiner did not provide
evidence that the sustained release formulations would have reasonably
suggested the claimed composition with a lag or delay release period.
The Examiner cited coatings from Curatolo's description of sustained-
dosage formulations for teaching the claimed (b) regulatory membrane
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coating on (a) the core. Specifically, the disclosure cited by the Examiner at
column 12 (Ans. 7) is a description of sustained dosage formulations.
Curatolo, col. 10, 11. 48-50. The more specific discussion of the delayed
release formulations begins at column 15, line 22 of Curatolo. The
Examiner appeared to acknowledge this fact, but stated that "there is no need
to go into the delay-release formulation section in CURATOLO, since most
of Appellant's claim limitations are found in column 12 of the
CURATOLO's reference." Ans. 21. We disagree with this statement
because there is a "need" to establish that the sustained release formulation
of Curatolo would result in the release rates required by the claims,
particularly with a lag or delay period. The Examiner did not adequately
address the lag/delay release limitation recited in the claims.
The coatings for the delayed-release formulation of Curatolo include
water soluble hydroxypropylmethylcellulose (Curatolo, col. 17, 1. 21 ), the
(1) water soluble gel-forming polymer of the claims. However, as argued by
Appellants, Curatolo does not disclose (2) a water-insoluble film-forming
polymer which is an alkyl cellulose as required by the claims. Appeal Br.
23. The Examiner acknowledged this argument, but once again referred to
the sustained release coatings. Ans. 23. Yet the Examiner did not establish
that the sustained release coatings would achieve the claimed lag and release
rates. Indeed, the fact that the polymers present in the sustained release
coatings are different from the delayed release coating suggests that
sustained release coatings would not achieve the claimed lag period and
release rates.
In sum, the Examiner did not provide adequate evidence that Curatolo
describes the claimed "regulatory membrane" having the recited lag and
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drug release rate. In contrast, the Examiner stated it was not necessary to
tum to the examples in Curatolo of delayed release formulations, but
provided no persuasive evidence that the sustained release formations
described in Curatolo enable or would achieve delayed release as claimed.
In addition to this, as noted by Appellants, Curatolo does not describe
(b) (1) a coating with high viscosity grade hydroxyalkylcellulose or methyl
cellulose as claimed. Appeal Br. 23. The Examiner cited Example 14 of
Curatolo for this limitation. Ans. 23. Example 14 of Curatolo describes a
sustained release matrix made with a high viscosity HPMC, K4M-CR.
Curatolo, col. 43 (Table 14-1 ). Example 14 does not contain a description of
a coating. The Examiner did not explain why one of ordinary skill in the art
would have used the high viscosity grade polymer in a coating, particularly
when, as argued by Appellants, the delayed release formulations use a low
viscosity HPMC. Appeal Br. 24, 27.
Because the Examiner did not meet the burden in establishing that the
cited Curatolo suggest the composition recited in claims 24 and 46, and
dependent claims 25-33, 35, 37, 39, 42, 45, and 47-51, the obviousness
rejection is reversed.
REVERSED
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